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Ensuring the Safety of FDA-Approved Drugs

June 16, 2017

Jeffrey Patrick, PharmD, was recently named director of the Ohio State Drug Development Institute, where he’ll lead implementation of clinical trials for cancer drug development and help foster communication between faculty researchers and pharmaceutical industry.

His diverse professional background and direct experience with guiding new drugs through the pipeline give him perspective on how hard the U.S. Food and Drug Administration (FDA) works to bring safe and effective medications to market.

Dr. Patrick recently commented on the importance of taking a measured approach to developing new medications, why the FDA approves drugs with some associated risks, and the value of continued medication safety monitoring when patients outside of controlled clinical settings begin to use newly released drugs.

Why are adverse events associated with drugs that have gone through the FDA’s rigorous review and approval process?

FDA investigators do a great job of balancing the risk-benefit profile of the compounds they’re asked to make available to the public. You have to appreciate a major limitation in the drug-approval process: The number of patients who are exposed to medications during clinical development is far smaller than the population who are exposed when products make it to market. One of the best examples of this reality involved COX-2 inhibitors, namely Vioxx. No early evidence from the clinical trial program suggested there were cardiac risk factors associated with some of the compounds. The issue was ultimately identified with vigilant post-approval reporting after approximately 2.5 million patients had been exposed to the drugs. The FDA, through a variety of adverse events reporting mechanisms, identified a pattern of cardiac risk. It was a very low-percentage adverse event that became apparent in a meaningful way only when a lot of patients took the drugs in the real-world setting.

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Is that why it’s important to continue monitoring the performance of medications after they’ve been approved?

Exactly. Controlled clinical development programs involve eliminating patients who might be at risk in order to expose a streamlined population to the drugs being tested. In the real world, that doesn’t apply. Patients who take the drugs have other diseases, are comorbid, and are on other medications that may or may not interact. That’s why the FDA insists on the use of pharmacovigilance and drug safety measures to closely monitor the performance of approved medications. Pharmacovigilance prevents drugs from doing more harm than good. For example, I was involved in bringing the first endothelin receptor antagonist to market. It was known to cause an elevation in drug liver enzymes, but it was the first of a class of drugs designed to treat pulmonary hypertension, which, when left untreated, would lead to death in an average of 3 years. We had to consider the risk of liver enzyme elevation against fatal disease. The FDA was worried about the risks involved, but decided to monitor the drug after approval to ensure it didn’t cause substantial liver injury.

Does the FDA have a sense of urgency to get effective and safe medications to market as quickly as possible?

The FDA recognizes unmet medical need and expedites the approval of drugs that represent landmark steps in improving patient outcomes, especially when there isn’t a drug available to treat certain conditions. The FDA convenes advisory panels made up of clinicians and medication experts to conduct independent validations of drugs based on feedback from frontline providers. Are the drugs safe? Are they effective? Are they better than what’s currently used? Is it unsafe in specific patient populations? Most FDA investigators are clinician researchers, so they understand the importance of approving valuable drugs that provide benefit and not too much harm—meaning adverse events are manageable or stop when the therapy is discontinued.

How do pharmacists ensure FDA-approved drugs are used safely?

They’re involved in batching medications, rounding with physicians, and being part of clinical teams that monitor drug adverse events and therapy efficacy. They work with savvy software that’s updated regularly to identify drug-drug interactions, drug-food interactions, and drug-disease interactions. Pharmacists’ impact on medication safety will continue to increase as patients ask more questions about the therapies they’re taking and as they work to ensure drugs are prescribed properly and effectively.

How have pharmacists taken on more responsibilities?

They’ve evolved into patient safety champions. Many pharmacists have also moved into industry on the innovator side of the business to educate clinicians about drugs. They’ve also expanded their roles in the delivery of patient care. Pharmacists truly represent a great bandwidth of ability — their scientific and clinical backgrounds make them uniquely positioned to improve patient safety. I’m proud to call myself one and proud to have served in several roles. I started out in clinical medicine, moved into the pharmacy, and now I’m back in the academic circle working in early drug development. There’s great opportunity for pharmacists to enhance safe patient care as they continue doing that good work in a variety of ways.

—Dan Cook

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